Kornimate/medical-research-clean huggingface dataset:
intraoral photobiomodulation therapy to prevent oral mucositis in patients undergoing hematopoietic cell transplantation

Conditions: Myeloablative Allogeneic Hematopoietic Cell Transplantation; Intraoral Photobiomodulation Therapy; Oral Mucositis; Mucosal Ulcer

Summary: this is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (allohct). patients who are planned for allohct will receive daily intraoral photobiomodulation therapy (pbmt) using a novel led device. the name of the study device involved in this study is: - thor lx2.3 with led lollipop

as part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of allohct as well as immunosuppressive medications to help prevent graft-versus-host disease ("gvhd prophylaxis"). together, these treatments will put patients at risk for developing side effects. a common side effect is oral mucositis (om), in which mouth sores develop making eating and speaking difficult and painful. photobiomodulation therapy (pbmt) is a light-based therapy that reduces inflammation and enhances wound healing. pbmt delivered inside the mouth has been shown to reduce om in patients undergoing allohct. the name of the study device involved in this study is: - thor lx2.3 with led lollipop this research study is a pilot study, which is the first time that investigators are examining this led based intraoral pbmt. the u.s. food and drug administration (fda) has not approved pbmt for this specific disease but it has been approved for other uses. the research study procedures include: screening for eligibility and study treatment including daily pbmt and clinical evaluations. participants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first. it is expected that about 20 people will take part in this research study

Eligibility criteria:
inclusion criteria: * planned to undergo myeloablative allogeneic hct using flubu4 conditioning and tac-mtx gvhd prophylaxis. * age ≥18 years. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * participants who have had treatment with intraoral pbmt within four weeks of admission for hsct. * participants who have a history of radiation therapy to the head and neck. * participants who have a history of photosensitivity or underlying disease with known photosensitivity. * participants who are planned to receive palifermin for om prevention.

Keywords: myeloablative allogeneic hematopoietic cell transplantation (hct) intraoral photobiomodulation therapy oral mucositis mucosal ulcer
psychoeducation for the parents of attention deficit hyperactivity disorder (adhd) children

Conditions: ADHD

Summary: this study designed and evaluated a psychoeducation program for parents of adhd children in terms of improving medication adherence and clinical benefits.

adhd is the most common behavioral disorder with poor outcomes. medication is the most important treatment for adhd. the adherence to the medication is extremely low. this study aims to investigate the the effect of a psychoeducation program for parents of adhd children. the investigators intent to recruit 80 adhd families. they will be randomized to intervention group and control group using a block randomization design. the intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in adhd at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. the control group only receives general consultation. the knowledge towards adhd and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.

Eligibility criteria:
inclusion criteria: * parents of adhd children diagnosed with adhd * 6 - 16 years old; * first referral to the hospital; * candidate for medication according to both the doctor and the family exclusion criteria: * inappropriate for medication; * being illiterate of the parent or the primary caregiver; * unable to be followed-up.
the effectiveness of soft tissue vibration in reducing pain of local anesthesia injection in adult dental patients

Conditions: Anesthetics, Local

Summary: the clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. the primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status class i * planned for multiple dental treatments in the maxilla and mandible bilaterally exclusion criteria: * patients \<18 years old * pregnant ladies * smokers and alcoholics * patients on medications * drug abusers * never received dental treatment under local anesthesia before * patients with an acute infection with or without fever * patients with preoperative pain
lidocaine injection versus sham needling in treating whiplash associated disorder

Conditions: Whiplash Injuries; Neck Pain

Summary: to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.

this is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.

Eligibility criteria:
inclusion criteria: * fulfill the grade ii quebec task force classification of wad, * with identifiable myofascial trigger points ( which occur with or without a taut band), * reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points * aged 18 to 70 * a good understanding of informed consent and willing to attend this trial. exclusion criteria: * have serious injury such as fracture and internal bleeding * suspicion of upper cervical instability or neurological deficits * clinical evidence of radiculopathy * a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia * anticoagulant medication user * previous experience with any type of needling for myofascial pain

Keywords: whiplash, injection, lidocaine, sham needling
tailored drug titration using artificial intelligence

Conditions: Hypertension

Summary: the purpose of the artery outcomes study is to compare optima-for-blood pressure (optima4bp), a clinical decision support system for hypertension (htn) treatment optimization to standard of care in patients with essential htn.

nearly 34 million americans have their blood pressure (bp) uncontrolled. hypertension (htn) claims 1000 deaths every day. despite medication and life-style management, the cost of htn associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital costs, with \>135 million emergency department (ed) visits. uncontrolled htn for even a few weeks is associated with increased risk for acute cardiovascular (cvd) events \[stroke, heart failure (hf), myocardial infarction (mi)\] and death. medication treatment optimization to bp goal reduces the incidence of stroke by 35-40%, hf by up to 64%, and mi by 15-25%. optima-for-blood pressure \[optima4bp\] transforms the episodic and reactive nature of uncontrolled htn pharmacological treatment management into a process that is continuous, proactive, and personalized. the innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.

Eligibility criteria:
inclusion criteria: * two or more blood pressure (bp) readings of ≥ 140/90 mmhg during ucsf primary care or cardiology office visits within the last 12 months * therapy with medications from at least 1 anti-htn pharmacological agents at the time of the last office visit * at least minimally "tech-savvy" defined as ownership of a compatible smartphone and ability to access the internet * active electronic health record mychart account exclusion criteria: * home anti-htn medication therapy doesn't match the electronic health record medication list * anti-htn medication therapy changed within 30 days prior to enrollment * inability to operate a bp cuff * incompatible smartphone device (galaxy s5 android 5.0) * less than minimally "tech-savvy" defined as inability to use the internet * non-compliance with medical follow-up (\>3 "no shows" in the previous 12 months) * planned coronary revascularization in the next 12 months * myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days * gfr \< 30 (ckd stage iv/ v) * treating physician rules out the patient due to superseding health management concerns * treating physician rules out the patient due to other concerns
phase 1 trial of btm-3566 in relapsed/refractory mature b cell lymphomas

Conditions: Lymphoma, B-Cell

Summary: the goal of this clinical trial is to learn if bmt-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. it will also learn how well btm-3566 works to treat relapsed or refractory mature b cell lymphomas. the main questions it aims to answer are: what are the side effects of btm-3566 at different doses? what are the levels of btm-3566 in the blood at different timepoints around dosing? what is the clinical benefit of btm-3566 in treating cancer (i.e. how well does it slow or stop disease progression)? participants will: take btm-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing visit the clinic regularly for checkups and tests keep a diary of their dosing and weight

this is an open label, phase 1 dose escalation trial of btm-3566 in relapsed/refractory mature b cell lymphomas. dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of btm-3566. treatment will be given as two-week cycles, with btm-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. dlt window will be the first two cycles of therapy (days 1 to 28). all enrolled patients will undergo a baseline fdg-pet/ct scan within 3 weeks prior to starting therapy. fdg-pet/ct will be repeated at the start of cycles 3 and 5 or more frequently as clinically indicated. beginning at cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.

Eligibility criteria:
inclusion criteria: * must be age ≥18 years * must have a diagnosis of relapsed or refractory mature b cell lymphoma * must have measurable disease per response evaluation criteria in lymphoma (lugano classification) * must have an eastern cooperative oncology group (ecog) performance status (ps) 0-2 * must have a predicted life expectancy of ≥3 months * must agree to use adequate birth control throughout their participation and for 90 days following the last dose of btm-3566 exclusion criteria: * has primary cns lymphoma * has ongoing toxicities from prior anti-cancer treatment \> grade 1 * has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation * has received any anti-cancer therapy (including radiation of curative intent) \<28 days prior to administration of btm-3566 * has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation). * is pregnant or breastfeeding
arthroscopic coracoclavicular ligament reconstruction comparing two techniques

Conditions: AC Joint Dislocation

Summary: this study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. a further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.

a modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. a notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. in this new modified technique, new implants were introduced. the new implant hides the suture knot and less foreign material is needed. the purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. a further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.

Eligibility criteria:
inclusion criteria: clinical diagnosis of chronic acromioclavicular luxation exclusion criteria: severe new trauma after the treatment
the effect of mobile health application based on omaha system on symptoms and quality of life in covid-19 patients

Conditions: COVID-19; Symptoms and Signs; Quality of Life

Summary: purpose: the aim of this study is to evaluate the effects of nursing interventions made with a mobile health application (covos) developed based on the omaha system on the physical, psychosocial and cognitive symptoms and quality of life of patients diagnosed with covid-19, and continuing treatment at home. design: this is a single center, 1:1 randomized, single blind, parallel, active comparator trial. method: standard protocol items: recommendations for interventional trials (spirit) statement 2013 checklist used in study. the consort (consolidated standards of reporting trials) flowchart is used in this protocol. this study will carried out in a family health center, located within the boundaries of i̇zmit district of kocaeli province. the patients in the experimental group will be followed up with the covos app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the covos app. the patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue. hypothesis: in patients diagnosed with covid-19 followed at home with covos, symptom management and quality of life will be better in 1st, 2nd and 3rd months compared to the control group.


Eligibility criteria:
inclusion criteria: * patients with a positive polymerase chain reaction (pcr) test within the last 24-48 hours * patients whose symptoms started within the last 48 hours * patients experiencing at least one symptom * patients diagnosed with covid-19 and continuing treatment at home * literate patients * patients with smartphone exclusion criteria: * those who have had a previous covid-19 infection * patients with vision or hearing problems * patients with chronic disease * patients with mental illness * patients who do not have a smartphone * pregnant and postpartum patients * patients who did not agree to participate in the study

Keywords: omaha system mobile health app
oral treatment for orthopaedic post-operative pain with dexketoprofen trometamol and tramadol hydrochloride

Conditions: Acute Pain

Summary: this study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (dkp) and tramadol hydrochloride (tram) in comparison to the single agents (and placebo for the single dose phase only) approximately 600 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

in this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). namely: * dkp/tram followed by dkp/tram; * dkp followed by dkp; * tram followed by tram; * placebo followed by dkp; * placebo followed by tram; * placebo followed by dkp/tram; the analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: dkp/tram, dexketoprofen, tramadol, and placebo. the analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: dkp/tram, dexketoprofen, and tramadol.

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 to 80 years. females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method. * scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis. * patients experiencing pain at rest of at least moderate intensity the day after surgery. exclusion criteria: * patients not suitable for study treatments and rescue medication (rm) or those for whom non-steroidal anti-inflammatory drugs (nsaids), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated. * patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ecg at screening. * patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results. * patients using and not suitable to withdraw analgesics other than those specified in the protocol. * patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol. * pregnant and breastfeeding women.

Keywords: moderate to severe acute pain postoperative pain hip arthroplasty analgesics dexketoprofen tramadol
validation of a non-motor fluctuation assessment instrument (nomofa) for parkinson's disease

Conditions: Parkinson Disease

Summary: investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (nmfs) in individuals with parkinson's disease (pd). to date, 189 participants with pd have been assessed for preliminary data analysis prior to developing the penultimate version. at this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory nmfs in pd patients with motor fluctuations and their impact on quality of life in parkinson's disease.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease (according to the united kingdom parkinson's disease society brain bank clinical diagnostic criteria) * stage of symptoms is mild, moderate or severe as per the hoehn \& yahr scale * have motor fluctuations * have non-motor fluctuations exclusion criteria: * atypical parkinsonism * lack of motor fluctuations * lack of english language proficiency in either subject or caregiver

Keywords: non-motor fluctuation
clinical study of hr20013 for injection in patients with malignant solid tumors

Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Summary: to evaluate the efficacy and safety of hr20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older, of either gender 2. has a diagnosed malignant tumor 3. has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy 4. predicted life expectancy of ≥ 3 months 5. has a performance status (ecog scale) of 0 to 1 6. adequate bone marrow, kidney, and liver function 7. women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment 8. able and willing to provide a written informed consent exclusion criteria: 1. scheduled to receive any radiation therapy to the abdomen or pelvis from day -7 through day 8 2. scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from day 2 through day 8 3. has taken the following agents within the last 48 hours 5-ht3 antagonists, phenothiazines, benzamides, domperidone, cannabinoids, benzodiazepines 4. subjects receiving palonosetron hydrochloride within 14 days before randomization 5. subjects who previously received nk-1 receptor antagonists within 28 days prior to randomization 6. subjects with a history of myocardial infarction or unstable angina pectoris 7. subjects with atrioventricular block or cardiac insufficiency 8. subjects with poor blood pressure control after medication 9. subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension 10. subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization 11. participated in clinical trials of other drugs (received experimental drugs) 12. the investigators determined that other conditions were inappropriate for participation in this clinical trial